SureSmile® 2000Recalls & reported problems
Orametrix, Inc. · SureSmile Aligner · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00856379007313), received between Jul 17, 2026 and Sep 29, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Appears to Trigger Rejection1
- Sharp Edges1
Patient problems
- Hypersensitivity/Allergic reaction1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Appears to Trigger Rejection
It was reported that a patient experienced a possible allergic reaction.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 50936731 ↗MalfunctionJul 17, 2026Sharp Edges
Patient problems: Laceration(s)
MAUDE report 25853561 ↗
Other Aligner, sequential devices
- Byte Day Alignes HBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,719 reports
- Byte Night Aligners NBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,053 reports
- sequential aligner 100-0352Access Dental Lab, LLC · Aligner, Sequential322 reports
- Invisalign System - Comprehensive 9000Align Technology, Inc. · Aligner, Sequential239 reports
- SureSmile® 1000Orametrix, Inc. · Aligner, Sequential134 reports
- REFINEMENT CORRECTION KIT 100-0012Access Dental Lab, LLC · Aligner, Sequential120 reports
- Candid Aligner FA-0001Candid Care CO. · Aligner, Sequential54 reports
- 3M™ Clarity™ 359-8363m Unitek Corporation · Aligner, sequential1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.